More Johnson & Johnson Drugs Recalled for Musty SmellJun 16, 2010 | Parker Waichman LLP
Johnson & Johnson is recalling more over-the-counter medicines made by its McNeil Consumer Healthcare unit. In a press release, the company said it failed to recall the medications – four lots of Benadryl allergy tablets and one lot of Extra Strength Tylenol gels – in a wider recall of over the counter drugs on January 15.
The January recall was issued for medications made at a McNeil plant in Puerto Rico, and was prompted by consumer complaints of a musty smell. The public was first made aware of the problems last November, when McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles. The recall was expanded twice, in December and on January 15, and eventually came to include various lots of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the recall involved about 53 million bottles of the medications.
In addition to the musty smell, some consumers had complained of stomach problems after taking the recalled Tylenol. The U.S. Food & Drug Administration (FDA) later criticized McNeil for waiting a year to notify it of the odor problems with adult Tylenol pills made at the Puerto Rico plant.
When the first recall was issued, the company said the odor problem had stemmed from traces of a chemical called TBA, caused by the breakdown of a chemical applied to wood used to build pallets that transport and store product packaging materials. It continues to maintain that the risk of medical problems from any of the recalled drugs is remote.
This is Johnson & Johnson’s fourth recall in a year, and comes only months after it recalled dozens of children’s over-the-counter medicines, including Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid because of manufacturing problems. Those drugs were made at a Pennsylvania facility that has been closed temporarily so that McNeil can address the manufacturing deficiencies that led to the recall.
The latest recall surely won’t help Johnson & Johnson’s already tarnished reputation. The drug maker was already facing a congressional probe, as well as the specter of an FDA criminal investigation over the children’s medicine recall and other issues.
“This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson,” Edolphus Towns, chairman of the House Oversight and Government Reform Committee, which is conducting an investigation of Johnson & Johnson’s manufacturing practices, said in a statement. “I am troubled by what we have learned so far in our investigation and this latest development adds to my concern.”